An interventional study of Usual care and Self-management in Hypertension, sponsored by Xu Lei. Status unknown at 1 site in China. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-09-29.
Sponsored by Xu Lei · Not applicable, Interventional, and Health services research
This three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine Model (PCTM) with usual care and self-care in community hypertension management in China.
Background: Hypertension is a major risk factor for cardiovascular diseases and its control rate has remained low worldwide. Studies have found that telemonitoring blood pressure (BP) helped control hypertension in randomized controlled trials. However, little is known about its effect in a structured primary care model in which primary care physicians (PCP) are partnering with cardiology specialists in electronic healthcare data sharing and medical interventions. This study aims to identify the effects of a coordinated PCP-Cardiologist model that applies telemedicine tools to facilitate community hypertension control in China.
Methods/Design: Hypertensive patients receiving care at four community healthcare centers (CHCs) that are academically affiliated to Shanghai Chest Hospital, Shanghai JiaoTong University are eligible if they have uncontrolled blood pressure in the previous three months and access to mobile internet. Study subjects are randomly assigned to three interventional groups: 1) usual care; 2) home-based BP tele-monitor with embedded GSM module and unlimited data plan, an App to access personal healthcare record and receive personalized lifestyle coaching contents, and proficiency training of their use; or 3) this plus coordinated PCP-Cardiologist care in which PCPs and cardiologists share data via a secure CareLinker website to determine interventional approaches. The primary outcome is mean change in systolic blood pressure (SBP) over a 12-month period. Secondary outcomes are changes of diastolic blood pressure (DBP), HbA1C, blood lipids, and medication adherence measured by the eight-item Morisky Medication Adherence Scale MMAS.
Discussion: This study will determine whether a coordinated PCP-Cardiologist Telemedicine Model (PCTM) that incorporates the lasted telemedicine technologies will improve hypertension care. Success of the model would help streamline the present community healthcare processes and impact a greater number of uncontrolled hypertensive patients.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 330 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →This is the only study on the registry with Xu Lei as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients are managed by their PCPs at the registered CHCs as usual.
Other: Usual care
* BP tele-monitor \& App based self-management supports * Patient proficiency training
Device: Self-management
* BP tele-monitor \& App-based self-management supports * Patient proficiency training * PCP \& cardiologist training of using Web-based analytics * Proactive and interactive care by PCPs and cardiologists
Other: PCTM intervention
The hypertension care of this arm complies with the national guideline and includes designated follow-ups by PCPs once every 1-3 months for stage-1 (≥ 140/90 mm Hg) hypertension patients, once every 1 month for stage-2 (≥ 160/100 mm Hg) and once every 2 weeks for stage-3 (≥ 180/110 mm Hg) patients.
* Usual care * Patients receive a BP telemedicine system developed by CareLinker Inc. (Shanghai, China) to facilitate BP self-management in addition to all the usual care components. The system consists of: 1) a BP tele-monitor with embedded GSM module that can upload BP readings; 2) a mobile App that allows patients to manually input healthcare data, display history BP measurements and lab test results, receive personalized lifestyle coaching contents and medication reminders, and communicate with PCPs through text-messaging. * All patients receive proficiency training in using the BP tele-monitor, and mobile App.
* Usual care * Self-management * PCPs and cardiologists use the secure CareLinker website to review patient data including BP measurements, lab test results and medications in use and comorbidities. The auto analytics tools of the website reveal BP average, BP trend, and risk score of each patient. Text alerts of abnormal BP variability will be pushed to PCPs' App when they occur and proactive interventions including phone consultation and medication dosage adjustment will be offered. A case review session will be set once every 1-2 months for PCPs and cardiologists to exam patients' disease progresses. The proprietary web-based analytic module also produces automated individualized medication recommendations to PCPs. * PCPs and cardiologists receive training of the CareLinker website.
Changes in mean SBP
The primary endpoint of the trial is changes in mean SBP from baseline (T1) to 12 months (T3) measured using the BP tele-monitor (Bliss BL928). The 12 months BP readings will be determined by taking the average of three BP measurements at the follow-up visit to the CHC. All BP data are collected and uploaded simultaneously to the trial database.
Time frame: From baseline (T1) to 12 months (T3)
Changes in mean DBP
Changes of DBP will be determined at the same time as SBP, as described in the session of "Primary Outcome Measure"
Time frame: From baseline (T1) to 12 months (T3)
Hypertension control rate
Hypertension control rate defined as BP \< 140/90 mm Hg or \< 130/80 mm Hg (patients of diabetes or renal diseases) following the national guidelines, and changes in measures related to hypertension complications (HbA1C, BMI, and lipid levels) from baseline (T1) to 6 months (T2) and 12 months (T3).
Time frame: From baseline (T1) to 6 months (T2) and 12 months (T3)
Anti-hypertensive medication adherence
Adherence is assessed by self-report, eight-item Morisky Medication Adherence Scale MMAS modified to focus on BP drugs at baseline (T1) and 12 months (T3).
Time frame: At baseline (T1) and 12 months (T3).
Plan to share: No
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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